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NCT Number: NCT07344948

Single and Multiple Ascending Doses of NTX-253 in Healthy Participants and Participants With Stable Schizophrenia

This study will assess the safety, tolerability, and pharmacokinetics of NTX-253 following oral administration in both healthy adult participants as well as adult participants with stable schizophrenia.

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Key information

Conditions

Healthy Participants Mental Disorders Schizophrenia Schizophrenia Diagnosis Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Collaborative Neuroscience Research, LLC - CenExel

Los Alamitos, California, 90720, United States

Location status: Recruiting

Location contact

Recruitment

CONTACT

[email protected]

866-787-4257

About this study

This study will assess the safety, tolerability, and pharmacokinetics of NTX-253 following oral administration in both healthy adult participants as well as adult participants with stable schizophrenia. NTX-253 is an investigational drug being developed for the treatment of schizophrenia. The study will consist of a single ascending dose (SAD - Part 1a) phase which will include a food effect cohort, and a cerebrospinal fluid (CSF - Part 1b) cohort in healthy volunteers. Participants will receive a single dose of either oral NTX-253 or placebo. The multiple ascending dose (MAD - Part 2) phase will follow. In Part 2, participants will be dosed for 10 consecutive days with either NTX-253 or placebo. Each phase will include sequential escalating doses in healthy volunteers. Two cohorts in the MAD phase will include stable schizophrenic adult participants who have had antipsychotic medication withdrawn for up to 8 days prior to dosing with NTX-253.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Primary Inclusion Criteria:

  • Male or non-pregnant, non-lactating female participants, ages 18-55 who are not of childbearing potential, with a truly abstinent lifestyle, or agrees to use medically acceptable forms of birth control
  • Part 1 a/b, Part 2 Cohort 7 only: Body mass index (BMI) within the range ≥18.0 to ≤30.0 kg/m2
  • Participants in the food effect cohort must be willing to eat a single high fat breakfast
  • (Part 2 only): Stable schizophrenia participants (schizophrenia cohorts only)
  • Body mass index (BMI) within the range ≥17.5 to ≤36.0 kg/m2
  • Positive and Negative Syndrome Scale (PANSS) total score <80 at screening

Primary Exclusion Criteria:

  • (Part 1a/b, Part 2 Healthy): History of or current clinically significant medical or mental illness
  • Cancer diagnosis/treatment in the past 7 years
  • Acute or chronic gastrointestinal conditions that would interfere with drug tolerance or absorption
  • Any clinically significant, abnormal 12 lead ECG
  • Part 2: Any primary DSM-5TR disorder other than schizophrenia
  • Participants with schizophrenia who are considered resistant/refractory to antipsychotic treatment by history; history of clozapine use.

Treatment and study plan

NTX-253

Drug

Oral Capsule

Placebo

Drug

Oral capsule

Primary outcomes

  1. Number of reported Adverse Events

    Time frame: From baseline until Day 8 after a single dose, Day 17 (healthy volunteers) or Day 35 (participants with stable schizophrenia).

    Safety and tolerability will be assessed by the incidence and severity of treatment-emergent adverse events.

  2. Number of Adverse Events of Special Interest (AESI)

    Time frame: From baseline until Day 8 after a single dose, Day 17 (healthy volunteers) or Day 35 (participants with stable schizophrenia).

    Safety and tolerability will be assessed by the incidence and severity of AESIs.

  3. Number of dose limiting treatment emergent adverse events (TEAE)

    Time frame: From baseline until Day 8 after a single dose, Day 17 (healthy volunteers) or Day 35 (participants with stable schizophrenia).

    Safety and tolerability will be assessed by the incidence and severity of serious or dose limiting TEAEs.

  4. Vital Signs: Change in blood pressure

    Time frame: From baseline until Day 8 after a single dose, Day 17 (healthy volunteers) or Day 35 (participants with stable schizophrenia).

    Blood pressure measurements

  5. Vital Signs: Change in temperature

    Time frame: From baseline until Day 8 after a single dose, Day 17 (healthy volunteers) or Day 35 (participants with stable schizophrenia).

    Oral temperature measurement

  6. Vital Signs: Change in respiratory rate

    Time frame: From baseline until Day 8 after a single dose, Day 17 (healthy volunteers) or Day 35 (participants with stable schizophrenia).

    Respiratory rate (number of breaths per minute) measurements

  7. Vital Signs: Change in heart rate

    Time frame: From baseline until Day 8 after a single dose, Day 17 (healthy volunteers) or Day 35 (participants with stable schizophrenia).

    Pulse measurements.

  8. Change in physical examination

    Time frame: From baseline until Day 8 after a single dose, Day 17 (healthy volunteers) or Day 35 (participants with stable schizophrenia).

    Investigator will perform complete physical exam and document any clinically significant conditions.

  9. Clinical Laboratory Tests

    Time frame: From baseline until Day 8 after a single dose, Day 17 (healthy volunteers) or Day 35 (participants with stable schizophrenia).

    Hematology, serum chemistry, urinalysis, and coagulation tests.

Secondary outcomes

  1. Maximum observed plasma concentration (Cmax) [Pharmacokinetics]

    Time frame: From baseline until up to 168 hours after a single dose, or until up to 168 hours after the last dose in the multiple dose cohorts.

    Samples will be collected periodically until:

    • 72 hours after a single dose with optional samples collected at 96, 120, 144, and 168 post-dose.
    • 72 hours after multiple doses with optional samples collected at 96, 120, 144, and 168 hours after the last dose.

  2. Time of Cmax (tmax) [Pharmacokinetics]

    Time frame: From baseline until up to 168 hours after a single dose, or until up to 168 hours after the last dose in the multiple dose cohorts.

    Samples will be collected periodically until:

    • 72 hours after a single dose with optional samples collected at 96, 120, 144, and 168 post-dose.
    • 72 hours after multiple doses with optional samples collected at 96, 120, 144, and 168 hours after the last dose.

  3. Apparent terminal half-life (t1/2)

    Time frame: From baseline until up to 168 hours after a single dose, or until up to 168 hours after the last dose in the multiple dose cohorts.

    Samples will be collected periodically until:

    • 72 hours after a single dose with optional samples collected at 96, 120, 144, and 168 post-dose.
    • 72 hours after multiple doses with optional samples collected at 96, 120, 144, and 168 hours after the last dose.

  4. Amount of unchanged drug excreted in urine (Ae) [urinary excretion)

    Time frame: From baseline until 72 hours after a single dose, or until the last dosing on Day 10 in the multiple dose cohort.

    Samples will be collected in select cohorts from baseline until 72 hours after a single dose, or at baseline and on the last dosing day after multiple dose administrations.

  5. Percent of dose excreted as unchanged drug in urine (Ae%) [urinary excretion]

    Time frame: From baseline until 72 hours after a single dose, or until the last dosing on Day 10 in the multiple dose cohort.

    Samples will be collected in select cohorts from baseline until 72 hours after a single dose, or at baseline and on the last dosing day after multiple dose administrations.

  6. Renal clearance (Clr) [urinary excretion]

    Time frame: From baseline until 72 hours after a single dose, or until the last dosing on Day 10 in the multiple dose cohort.

    Samples will be collected in select cohorts from baseline until 72 hours after a single dose, or at baseline and on the last dosing day after multiple dose administrations.

  7. Maximum observed CSF concentration (Cmax, CSF) [Pharmacokinetics]

    Time frame: From baseline until 12 hours after a single dose.

    CSF samples will be collected at periodic intervals until 12 hours after a single dose in a single dose CSF cohort.

  8. Time corresponding to Cmax (Tmax, CSF) [Pharmacokinetics]

    Time frame: From baseline until 12 hours after a single dose.

    CSF samples will be collected at periodic intervals until 12 hours after a single dose in a single dose CSF cohort.

  9. QT/QTc potential interval prolongation and plasma concentration

    Time frame: From baseline until 72 hours post-dose in the single dose cohorts, then from baseline until Day 13 in the multiple dose cohorts.

    Electrocardiograms (ECGs) will be collected to assess the potential for QT/QTc interval prolongation and ΔQTc as measured by:

    • Change from baseline in cardiac measurements

Study contacts

Contact information is provided by the study sponsor or research team.

Doug Feltner, Chief Medical Officer, MD

CONTACT

[email protected]

+41 22 884 15 55

Lisa Corey

CONTACT

[email protected]

+41 22 884 15 55

Sponsors and collaborators

Lead sponsor

Neurosterix

Industry

Registry information

Official study title

A First in Human, Phase 1/1b Study of Single and Multiple Ascending Dosing Administration of NTX110253 in Healthy Participants and Participants With Stable Schizophrenia

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 15, 2026
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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